July 9, 2020
As innovative devices and first-of-kind products enter China market, NMPA seeks to strengthen the clinical trial approval requirements for certain devices. Not all of them require NMPA clinical approval to […]
July 8, 2020
NMPA granted fast-track channel status to two domestic AI-infused software on June 29, 2020: Innovation Status Zhiyuan Huitu: Assistance software for fundus diagnosis Priority Review Status Hangzhou Yitu: Assistance software […]
July 2, 2020
NMPA granted Innovation Approval to Edwards Lifesciences’ Transcatheter Aortic Valve System on June 8. It is the 14th device obtained such approval in 2020. Balloon Technology The product includes transcatheter […]
June 22, 2020
NMPA issued four orthopedic guidelines on June 9, 2020 to guide manufacturers for local type testing and regulatory approval. Registration Guideline on 3D printed acetabular cup products Registration Guideline on […]
June 22, 2020
“Regulations on the Management of Imported Medical Devices Urgently Needed in the Hainan Pioneer Zone” was published by Hainan government on June 2, 2020. This important document mandates the qualification […]